Surgical repair kit and its method of use

ABSTRACT

A suture passer comprises a longitudinally extending hollow cannula having a central passage slidingly receivable of a surgical suture; a manually graspable handle connected to the hollow cannula for manipulation thereof, the handle having an upper surface; first guide means, connected to the upper surface of the handle, proximate a distal end of the handle for releasably, guidingly, holding the surgical suture; second guide means, connected to the upper surface of the handle, proximate to the first guide means, for releasably, guidingly, holding the surgical suture. The suture passer can be provided in a kit, for use in the suturing of internal tissue, along with a cannula bender, various hollow surgical needles and surgical suture material. The suture passer finds particular use in the suturing of internal tissues which are at least partially accessible through a body cavity, e.g. arthroscopic surgery.

This is a continuation-in-part of my prior, co-pending U.S. patentapplication Ser. No. 08/090,651, filed Jul. 12, 1993, entitled "ASURGICAL REPAIR KIT AND ITS METHOD OF USE".

FIELD OF THE INVENTION

The present invention relates to medical devices for performing surgeryand a surgical repair kit containing the same. More particularly, thepresent invention is directed to a surgical repair kit useful forperforming arthroscopic meniscal repairs and other surgical procedures.

BACKGROUND OF THE INVENTION

Menisci are tough rubbery "C" shaped cartilage cushions that areattached by ligaments to the top (plateau) of the tibia. They preventthe surfaces of the tibia and femur from grinding against each other andact as the shock absorbers in the knee.

Meniscal tears are a common problem in the United States, especiallyamong amateur and professional athletes. While menisci are also locatedin the shoulder, the most common meniscus injury occurs in the knee.There are two menisci in each knee. Each year, tens of thousands ofpeople suffer meniscal tears, particularly in or at the site of one orboth knees. If these tears are not repaired, there may be a progressivedeterioration of the cartilage, leading to the painful rubbing andwearing of bones which had previously been covered by cartilage. This,in turn, leads to inflammatory synovitis, arthritis and otherdebilitating ailments. Consequently there are at least 30,000 to 40,000meniscal excisions or repairs to the shoulder and the knee performedeach year.

Men and women between the ages of 18 and 45 experience the majority ofmeniscal tears, usually during athletic activity, such as when twisting,cutting, pivoting, decelerating or when being tackled. When torn, themeniscus may have a longitudinal, horizontal or radial ("parrot beak")tear.

The damaged meniscus may be diagnosed with the assistance or use ofmagnetic resonance imaging (MRI) and/or an arthroscopic examination.Arthroscopy enables a surgeon to look into the joint using a miniaturevideo camera. In many cases, torn fragments of the meniscus are removedarthroscopically. In other cases, a small tear at the periphery of themeniscus with a very swollen knee joint may be treated by draining thejoint, temporarily restricting the use of the knee, and slowly havingthe patient begin rehabilitative exercises.

However, in still other cases, the tears in the meniscus do requiresurgical repair, normally by sewing the torn sections of the meniscustogether. The use of the arthroscope greatly aids in the surgical repairof the meniscus by allowing the surgeon to better visualize the smallareas between which the torn meniscus lies. The arthroscope enables thesurgeon to visualize the interior of the joint and to perform surgerythrough small puncture holes without having to open the joint as hasbeen done in the past.

A number of surgical tools have been developed to assist in suturing,and in particular the suturing of the meniscus.

U.S. Pat. No. 2,808,055 (Thayer) discloses a surgical stitchinginstrument which accommodates a bobbin of suture material and includemeans to feed the suture material to a needle. A slidable thread movingmember is provided for advancing the suture material through the needle.

U.S. Pat. No. 3,476,114 (Shannon, et al.) discloses a ligating implementcomprising an elongated instrument through which a ligature passes toform a loop at one end with a disc. The disc provides a means wherebythe loop may be drawn tight above a severed vessel of the like.

U.S. Pat. No. 3,476,115 (Graeff, et al.) discloses a ligating implementas in Shannon, et al., and includes severing means to preventoverstressing of the locking disc during tightening of the noose.

U.S. Pat. No. 4,493,323 (Albright, et al.) discloses a suturing deviceand a method for its use in arthroscopic surgery. The suturing devicecomprises an elongated tube and plunger which are used to hold andadvance a pair of needles united by a length of suture material.

U.S. Pat. No. 4,641,652 (Hutterer, et al.) discloses an applicator fortying sewing threads which comprises a helical tubular coil connected toa shaft having an axial passage. A catcher loop is extendable throughthe shaft to catch a sewing thread inserted manually into the coilpassage.

U.S. Pat. No. 4,935,027 (Yoon) discloses surgical instruments andmethods for effecting suturing of tissue controlled from a positionremote from the suture site. The invention provides for the continuousfeeding of suture material through opposed forcep jaw members betweenwhich the tissue segments are interposed.

U.S. Pat. No. 5,112,308 (Olsen, et al.) discloses a medical device forand a method of endoscopic surgery. The device includes a dilator havinga tapered end and a central passage which accommodates a guide wire fordirecting the dilator. This device does not include any means wherebythe guide wire may be secured to the dilator or otherwise manipulated inconjunction therewith.

U.S. Pat. No. 4,779,616 (Johnson) discloses a method for snagging an endof a surgical suture during arthroscopic surgery, comprising deploying adistal end of a cylindrical cannula adjacent to the end of the suturewithin the body and passing a resilient loop through the cannula to snagthe suture.

U.S. Pat. Nos. 4,890,615, 4,923,461 and 4,957,498 (Caspari, et al.)discloses a suturing instrument and method of use in arthroscopicsurgery. The suturing instrument includes a hollow needle forpenetrating tissue to be sutured within the body while the tissue isclamped between relatively movable jaws and a suture feed mechanism forfeeding suture material through the hollow needle. The jaws can beopened and the suturing instrument withdrawn from the body, pulling thefree end segment of the suture material with the instrument.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a surgical repairkit. In particular, it is an object of the present invention to providea surgical repair kit which is particularly suited for the repair oftorn menisci.

It is another object of the present invention to provide a suture passerhaving means for positioning of the suture.

It is another object of the present invention to provide a parallelneedle guide to allow for an easier and more successful placement of asecond needle in close proximity to the first needle that has beenpreviously inserted in the area of a tissue tear.

Another object of the present invention is to provide a modular suturepasser assembly of the sort comprising a handle and a cannula, whereinthe handle is adapted to releasably and lockingly hold the cannula formanipulation by a surgeon so that a length of suture may be passedthrough tissue.

Still another object of the present invention is to provide a surgicalkit for use in passing a length of suture through tissue, wherein thekit comprises a handle and various interchangeable cannulas, with eachcannula being adapted to be releasably and lockingly held by the handleduring a surgical procedure.

Yet another object of the present invention is to provide a surgicalcannula having a sharp distal tip which is adapted to pierce tissue.

And another object of the present invention is to provide a surgicalcannula having a sharp distal tip which is adapted to pierce tissuewhile at least one strand of suture extends out of the cannula's sharpdistal tip, wherein the sharp distal tip of the cannula is speciallyconfigured so as to minimize the possibility of damaging or severing thesuture during the tissue piercing operation.

Still another object of the present invention is to provide a modularsuture passer assembly which is relatively simple to manufacture andrelatively easy to use.

Yet another object of the present invention is to provide a new methodfor passing suture through tissue.

While the present invention is primarily concerned with the repair oftorn menisci, the repair kit, the parallel needle guide, and the suturepasser may be used in other surgical procedures, e.g. for suturinginternal tissue at least partially accessible through a body cavity.

The suture passer of the invention comprises a longitudinally-extendinghollow cannula having a central passage slidingly receivable of asurgical suture and a manually graspable handle connected to the hollowcannula for manipulation thereof. The suture passer has a first guidemeans connected to an upper surface of the handle, proximate to a distalend of the handle for releasably, guidingly holding the surgical suture,and a second guide means connected to the upper surface of the handle,proximal to the first guide means for releasably, guidingly holding thesurgical suture.

In one embodiment of the invention, the hollow cannula is connected tothe upper surface of the handle and the hollow cannula terminates at arearward opening between the first and second guide means.

In another embodiment of the invention, the hollow cannula is receivedwithin a bore formed in the handle, with the bore terminating at anopening in the upper surface of the handle between the first and secondguide means.

The guide means may be loops which are either parallel or transverse tothe longitudinally-extending hollow cannula. In an alternativeembodiment, the second guide means may consist of a plurality of bentfingers lying in parallel planes.

The guide means serve as means about which the suture is passed so itmay be manipulated longitudinally with respect to the cannula. Thediameter of the central passage of the cannula is such that the tip of aspinal epidural or similar needle into which the suture is directed mayfit into the cannula and is large enough to allow the sliding passage oftwo surgical sutures (i.e. the two limbs of a single surgical suture).In the method of use, the suture passer is used in surgicalmanipulations, and in particular meniscal repairs or other arthroscopicprocedures to direct a suture within a joint space with a greater degreeof precision than available by current methods.

When the two limbs of a surgical suture are within the cannula, theguide means function to separate the two limbs. Separation of the limbsof the surgical suture allows independent manipulation of the suturelimbs. Digital manipulation of the surgical suture between the first andsecond guide means causes longitudinal passage of one limb of thesurgical suture within the cannula, i.e. friction between the digit andthe said suture will cause the said suture to slide along the topsurface of the handle, into or out of the cannula, when manipulateddigitally.

In one surgical repair kit formed in accordance with the presentinvention, the kit comprises a suture passer, as previously described,at least two surgical needles of predetermined length and at least onestylet for each surgical needle. Preferably, the surgical repair kitincludes three surgical needles, with one of the surgical needles havinga length greater than that of the other needles.

In one preferred embodiment, the suture passer is provided with a metalcannula, and the surgical repair kit includes a cannula bender forbending the metal cannula in a desired manner. The cannula bendercomprises a base and a pair of upwardly stepped symmetrical bolsterspositioned on top of the base allowing the cannula to be bent to theright or to the left, each step of each bolster having a predeterminedradius of curvature wherein the radius of curvature of each step issmaller than the radius of curvature of the step immediately below.

Additionally, in one surgical repair kit formed in accordance with thepresent invention, the kit may further include a parallel needle guidefor guiding the surgical needles for desired placement relative to eachother. The parallel needle guide comprises at least three longitudinallyextending, hollow tube-shaped units longitudinally adhered to eachother, in a plane, parallel to one another, each of the tube-shapedunits slidingly receivable of a surgical needle therethrough.

The present invention also provides methods for the suturing of internaltissue which is at least partially accessible through a body cavity.

A first method comprises the steps of:

(A) providing at least one suture having a first limb and a second limb;

(B) providing a suture passer comprising a longitudinally extendinghollow cannula having a distal opening, a proximal opening and a centralpassage slidingly receivable of a surgical suture;

(C) introducing the distal end of the cannula into a body cavity atleast partially accessing internal tissue to be sutured:

(D) identifying a first insertion site for passing a first limb of asuture through the internal tissue to be sutured;

(E) inserting a first hollow needle through the first insertion site,the hollow needle extending from outside the body through the firstinsertion site into the body cavity;

(F) identifying a second insertion site for passing a second limb of thesuture through the internal tissue to be sutured;

(G) inserting a second hollow needle through the second insertion site,the hollow needle extending from outside the body through the secondinsertion site into the body cavity;

(H) passing the second limb of the suture through the first hollowneedle into the distal opening of the cannula until it exits theproximal opening of the cannula;

(I) feeding the second limb of the suture back into the cannula throughthe proximal opening;

(J) passing the second limb of the suture through the hollow cannulainto the second hollow needle until it exits the needle external of thebody;

(K) drawing the suture through the cannula into the body cavity;

(L) removing the first and second needles by drawing them outwardly ofthe body cavity;

(M) tying the limbs of the suture; and

(N) repeating steps (D)-(M) until a surgically sufficient number ofsutures have been tied.

A second method comprises the steps of:

(A) providing at least one suture having a first limb and a second limb;

(B) providing a suture passer comprising a longitudinally-extendinghollow cannula having a distal opening, a proximal opening and a centralpassage slidingly receivable of a surgical suture;

(C) loading the suture passer with a surgical suture such that an end ofthe first limb of the suture and an end of the second limb of the sutureeach protrude from the distal end of the cannula;

(D) introducing the distal end of the cannula into a body cavity atleast partially accessing internal tissue to be sutured;

(E) identifying a first insertion site for passing the first limb of thesuture through the internal tissue to be sutured;

(F) inserting a first hollow needle through the first insertion site,the hollow needle extending from outside the body through the firstinsertion site into the body cavity;

(G) identifying a second insertion site for passing a second limb of thesuture through the internal tissue to be sutured:

(H) inserting a second hollow needle through the second insertion site,the hollow needle extending from outside of the body through the secondinsertion site into the body cavity;

(I) introducing the end of the first limb of the suture into the firsthollow needle until it exits the first hollow needle outside the body;

(J) introducing the end of the second limb of the suture into the secondhollow needle until it exits the second hollow needle outside the body;

(K) drawing the suture through the cannula into the body cavity;

(L) removing the first and second hollow needles by drawing themoutwardly of the body cavity;

(M) tying the limbs of the suture; and

(N) repeating steps (C)-(M) until a surgically sufficient number ofsutures have been tied.

In a further modification of the invention, the suture passer may beformed in a modular fashion so that a variety of different cannulas canbe attached to its handle. These cannulas may be blunt or sharplypointed, and they may be straight or curved, as required for aparticular surgical procedure. In this form of the invention, the suturepasser's handle includes a female lock portion which is configured toreceive and lockingly hold a cannula which is provided with acorresponding male lock portion.

In a preferred form of the modular suture passer, each of theinterchangeable cannulas is provided with a radial fin which is attachedto the cannula adjacent to the cannula's proximal end. This fin includesa main portion and a tab portion. The tab portion of the fin extendsproximally from the main portion of the fin. The tab portion of the finincludes an upper tab projection defining an upper, distally facing tabshoulder and a lower tab projection defining a lower, distally facingtab shoulder. The tab portion's upper and lower tab projections arelocated between the main portion of the fin and the proximal end of thetab portion. The tab portion's upper and lower tab shoulders are alignedwith one another.

The modular handle includes first and second suture guide meansgenerally of the sort disclosed above.

The modular handle also comprises a first bore which extends proximallyand axially into the handle from the distal end thereof. The first boreincludes a stop at its proximal end. The first bore is sized andpositioned so that it can receive the proximal portion of a selectedcannula, with the proximal end of the cannula's central lumen openingonto the upper surface of the handle between the first and second guidemeans when the cannula's proximal end is in engagement with the firstbore's stop. A slot extends proximally and axially into the handle fromthe distal end thereof. The slot communicates with the handle's firstbore and is sized to receive the main portion of the fin of a cannulawhen that cannula is mounted to the handle.

A cavity is formed in the handle immediately proximal to the slot. Thiscavity is sized to receive the tab portion of a cannula when thatcannula is mounted to the handle. An upper sidewall projection extendsinwardly into the cavity from one of the sidewalls of the cavity, and alower sidewall projection extends inwardly into the cavity from the samesidewall of the cavity. The upper sidewall projection defines an upper,proximally facing sidewall shoulder, and the lower sidewall projectiondefines a lower, proximally facing sidewall shoulder. The upper andlower sidewall shoulders are aligned with one another. The upper andlower sidewall projections are located such that as the tab portion of agiven cannula enters the handle's cavity, the cannula's upper and lowertab projections will snap over and lockingly engage the handle's upperand lower sidewall projections when the cannula is fully inserted intothe handle's first bore. In particular, when the assembly is in thislocked condition, the cannula's distally facing upper tab shoulder willengage the handle's proximally facing upper sidewall shoulder, and thecannula's distally facing lower tab shoulder will engage the handle'sproximally facing lower sidewall shoulder.

When a given cannula has been mounted to the handle in the foregoingmanner, rotational movement of the cannula relative to the handle isprecluded by the engagement of the cannula's main fin portion with thesidewalls of the handle's slot. In addition, axial movement of thecannula relative to the handle is precluded (i) in the proximaldirection by the engagement of the proximal end of the cannula with thestop located at the proximal end of the handle's first bore, and (ii) inthe distal direction by the engagement of the cannula's two distallyfacing tab shoulders with the handle's two proximally facing sidewallshoulders.

The handle of the modular suture passer also includes means forreleasing a cannula from its locking engagement with the handle. Moreparticularly, when a given cannula has been mounted to the handle in theforegoing manner, the proximal most portion of the cannula's tab portionwill extend proximally into a second bore formed in the handle. Thesecond bore extends axially through the handle, from the proximal end ofthe handle's cavity to the proximal end of the handle. A release rod ispositioned within the second bore for reciprocal movement therein,between (i) a proximalmost position in which the release rod iswithdrawn from engagement with a cannula mounted to the handle, and (ii)a distalmost position in which the release rod is in engagement with acannula mounted to the handle. Spring means are provided for yieldablybiasing the release rod into its proximalmost position. The release rodhas a bevelled distal end terminating a drive surface. A cannula isdismounted from the handle by urging the release rod from itsproximalmost position to its distalmost position. As the release rodbegins to move from its proximalmost position to its distalmostposition, the rod's bevelled distal end will first engage the proximalend of the cannula's tab portion and deflect the tab portion laterally,whereby the cannula's two distally facing tab shoulders will bedisengaged from the handle's two proximally facing sidewall shoulders.Thereafter, as the release rod continues to move from its proximalmostposition to its distalmost position, the release rod's drive surfacewill engage the proximal end of the cannula's tab portion, whereby theentire cannula will be driven distally so that the cannula's two tabprojections will clear the handle's two sidewall projections. This willunlock the cannula from the handle. The cannula may thereafter bemanually withdrawn from the handle by pulling the cannula in a distaldirection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of the suture passer.

FIG. 2 is a top view of another embodiment of the suture passer.

FIG. 3 is a side view of the suture passer of FIG. 2.

FIG. 4 is a frontal view of the handle of the embodiment of the surgicalsuture passer of FIG. 3.

FIG. 5 is a cross section of the handle of the surgical suture passer.

FIG. 6 is a side view of another embodiment of the surgical suturepasser.

FIG. 7A is a side view and FIG. 7B is a top view of another embodimentof the surgical suture passer.

FIG. 8A is an enlarged side view of a tip of a spinal needle and FIG. 8Bis an enlarged side view of a tip of an epidural needle.

FIG. 9 is a side view of a parallel needle guide.

FIG. 10 is a frontal view of a parallel needle guide.

FIG. 11 is a side section view of a needle containing a stylet.

FIG. 12 is a frontal view of a cannula bender.

FIG. 13 is a frontal view illustrating the use of the cannula bender.

FIG. 14-FIG. 26 are cross-sectional top views at various stages of anoperation where the middle third of the meniscus is being repaired.

FIG. 27A, FIG. 27B, and FIGS. 28-31 are cross-sectional top views atvarious stages of an operation where the posterior region of themeniscus is being repaired.

FIG. 32 is a left side view of a modular suture passer formed inaccordance with the present invention.

FIG. 33 is a right side view of the modular suture passer shown in FIG.32.

FIG. 34 is a top view of the modular suture passer shown in FIG. 32.

FIG. 35 is a bottom view, with portions broken away, of the modularsuture passer shown in FIG. 32.

FIG. 36 is a left side view similar to FIG. 32, except that the modularsuture passer's handle is shown in section so as to reveal how thecannula is in locking engagement with the handle.

FIG. 37 is a bottom view similar to FIG. 35, except that the modularsuture passer's handle is shown in section so as to reveal how thecannula is in locking engagement with the handle.

FIG. 37A is an enlarged bottom view showing selected portions of FIG. 37in greater detail.

FIG. 38 is a left side view similar to FIG. 36, except that the cannulais shown released from its locking engagement with the handle, with thehandle's release rod having moved from its proximalmost position to itsdistalmost position.

FIG. 39 is a bottom view similar to FIG. 37, except that the cannula isshown released from its locking engagement with the handle, with thehandle's release rod having moved from its proximalmost position to itsdistalmost position.

FIG. 39A is an enlarged bottom view showing selected portions of FIG. 39in greater detail.

FIG. 40 is an enlarged left side view, partially cut away, of a cannulasuitable for use with the modular suture passer shown in FIGS. 32-39.

FIG. 41 is a rear view of the cannula shown in FIG. 40.

FIG. 42 is a top view, partially cut away, of the cannula shown in FIG.40.

FIG. 43 is an enlarged top view of the pointed distal end of the cannulashown in FIG. 40.

FIG. 44 is an enlarged left side view, partially cut away, of anothercannula suitable for use with the modular suture passer shown in FIGS.32-39.

FIG. 45 is an enlarged left side view, partially cut away, of stillanother cannula suitable for use with the modular suture passer shown inFIGS. 32-39.

FIG. 46 is an enlarged left side view, partially cut away, of yetanother cannula suitable for use with the modular suture passer shown inFIGS. 32-39.

FIG. 47 is an enlarged left side view, partially cut away, of stillanother cannula suitable for use with the modular suture passer shown inFIGS. 32-39.

FIG. 48 is an enlarged left side view, partially cut away, of yetanother cannula suitable for use with the modular suture passer shown inFIGS. 32-39.

FIG. 49 is an enlarged left side view, partially cut away, of stillanother cannula suitable for use with the modular suture passer shown inFIGS. 32-39.

FIG. 50 is an illustrative side view showing the modular suture passerof FIGS. 32-39 adjacent to a piece of tissue, wherein a length of sutureextends through the suture passer's cannula, and further wherein thesuture end extending out of the distal end of the cannula engages thehandle's distal suture guide, and the suture end extending out of theproximal end of the cannula engages the handle's proximal suture guide.

FIG. 51 is an illustrative side view similar to that of FIG. 50, exceptthat the distal end of the cannula has been inserted through the pieceof tissue, carrying the length of suture with it.

FIG. 52 is an illustrative side view similar to that of FIG. 51, exceptthat the cannula has been withdrawn from the piece of tissue, leaving aloop of suture extending through the tissue, with the suture endextending from the distal end of the cannula having been disengaged fromthe handle's distal suture guide.

FIGS. 53-55 illustrate how a simple stitch can be established across twopieces of tissue using the present invention.

FIGS. 56-58 illustrate how a suture loop can be passed across two piecesof tissue using the present invention.

FIGS. 59-61 illustrate two different ways a folded suture loop can bepassed across two pieces of tissue using the present invention.

FIGS. 62-64 illustrate how a simple stitch can be converted to amattress stitch with a suture loop using the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1-7 illustrate the meniscal suture passer 1, used for the passageof a suture in a confined area of the body during surgery. The suturepasser 1 comprises a longitudinally extending hollow cannula 2 having acentral passage slidingly receivable of a surgical suture, and amanually graspable handle 3 connected to the hollow cannula 2 formanipulation thereof. A first guide means is connected to the uppersurface of the handle 3 for releasably, guidingly holding the surgicalsuture. A second guide means for guidingly holding the suture, is alsoconnected to the upper surface of the handle 3. The second guide meansis proximal to the first guide means. The suture passer 1 in FIGS. 1-6comprises the cannula 2, the handle 3, a rearward opening 4 near thedistal end of the handle 3, a distal loop 5, and a proximal loop 6. Thedistal loop 5 serves as the first guide means, and the proximal loop 6serves as the second guide means. Distal loop 5 preferably comprises asingle turn open wire loop having a first axis of rotation of the loopand proximal loop 6 is preferably a 11/2 pigtail open wire loop having asecond axis of rotation of the loop. The loops 5, 6 are preferablyparallel to one another. In one embodiment, the wire loops 5 and 6 arepreferably perpendicular to the handle 3 with the first axis of rotationand the second axis of rotation transverse to said longitudinallyextending hollow cannula 2. In another embodiment, the axes of rotationof loops 5 and 6 are parallel to the longitudinally extending cannula 3.Near the distal end of the handle there is the opening 4 which leadsfrom the handle 3 to the cannula 2. The handle preferably is providedwith gripping means and preferably is knurled at 7, so that the surgeonhas a better grip on the suture passer 1.

The cannula 2 may be attached and enter through an opening at theconcentric center of the handle 3 as shown in FIG. 1. The hollow cannula2 is received within a bore 8 formed in the handle 3 with the bore 8terminating at the opening 4 in an upper surface 9 of the handle 3intermediate the first and second guide means. In an alternativeembodiment, the cannula may be connected to the upper surface 9 of thehandle 3, as shown in FIG. 3. In this embodiment of the invention, thereis no opening into or through the handle 3. Instead, the hollow cannula2 terminates at a rearward opening 10 between the first and second guidemeans directly on top of the handle 3. Additionally, in the embodimentof FIG. 1, the handle of the suture passer is rounded, whereas in theembodiment of FIGS. 3 and 4, the suture passer handle 3 is flattened onthe side upon which the cannula 2 resides. Additionally, in theembodiment of FIG. 3, the distal loop 5 resides on the cannula 2 justprior to the proximal opening 10 of the cannula 2.

The central passage of the cannula should have a diameter large enoughto allow sliding passage of two surgical sutures therethrough. A distalopening 11 of the cannula should also have a diameter large enough toallow engagement with the tip of the spinal or epidural needle for thepurpose of passage of the suture between the cannula and the needle.

In the embodiment of FIG. 1, the cannula 2 from its distal opening 11 tothe point at which it enters the handle ranges in length from about 6.0cm to about 20.0 cm, and preferably is about 12.0 cm in length. Theopening of the cannula 2 is preferably from about 0.08 cm to about 0.32cm in width, and more preferable is about 0.16 cm in width. The wall ofthe cannula 2 is preferably from about 0.01 cm to about 0.05 cm inthickness, and more preferably is about 0.0254 cm in thickness. Thehandle preferably has a width ranging from about 0.64 cm to about 1.28cm, and more preferably is about 0.96 cm in width.

The wire of the wire loops as shown in FIG. 5 ranges from about 0.10 toabout 0.14 cm in diameter "a" and preferably is attached to the handleby a mounting structure 12 about 0.1 to about 0.4 cm in height "h".

In the embodiment of the invention illustrated in FIG. 6, the suturepasser 1 is similar to the invention illustrated in FIG. 3; however, thecannula 2 is flush with the flattened surface of the handle 1 bearingthe wire loops 5 and 6. A segmented piece 13 upon which the distal loop5 resides attaches the cannula 2 to the handle 3. The proximal opening10 of the cannula opens near the proximal side of the segmented piece13.

In all of the embodiments of the meniscus suture passer 1, the proximalloop 6 may be fitted anywhere along the length of the handle. However,it is preferable that the proximal loop 6 be fitted about halfwaybetween the ends of the handle of the suture passer.

In yet another embodiment of the invention, shown in FIG. 7A and FIG.7B, the first guide means comprises a single turn open loop lying in afirst plane, with the first plane disposed perpendicularly to thelongitudinally extending hollow cannula, and a second guide meanscomprises a plurality of bent fingers lying in parallel planes. Theplanes are parallel to each other and are perpendicular to thelongitudinally extending hollow cannula. The bent fingers may bealternately bent in opposite directions. As shown in FIGS. 7A and 7B,the second guide means may have 3 bent fingers 14, 15, 16.

The suture passer 1 may be made out of either plastic or metal, or acombination thereof, with the handle, loops, or cannula being plastic,metal or any combination thereof. The cannula of the meniscal suturepasser may be semi-rigid. The cannula should be rigid enough tostabilize the inner tear of the meniscus during the insertion of thespinal or epidural needle. Additionally, if made of plastic, the cannulashould be malleable enough that it can be bent by hand without the needof a special bender. After the cannula is bent it should not springback. Because of its malleable characteristics, the plastic material isless likely to damage the articular surface. If the suture passer isentirely made out of plastic, the entire suture passer device can beinjection molded as a single unit. If the handle is made out of plasticmaterial, the loop or the finger projections may be molded as anintegral part of the handle.

If the suture passer is made out of metals, however, the loops may bescrewed, riveted, or soldered onto the handle of the suture passer.

Frequently, surgical instruments and suturing devices must be adaptableto the environment or conditions in which they are being used. Morespecifically, because of the location of the menisci in the shoulder andin the knee, or because there is limited space in that part of the bodybeing repaired for the placement of surgical tools, especially duringsuturing, it is frequently advisable to adjust the shape of the cannulaof the suture passer or to bend the needles being used during suturingthe allow for the positioning of the instruments into or through thesurgical incision to allow for maximum visibility on the part of theoperating team and to avoid crowding of the incision area which wouldhinder the operating team.

Preferably included in the surgical repair kit when the cannula is madeout of metal is a cannula bender. The cannula bender may be used to bendthe cannula without kinking the cannula.

A cannula bender 30 shown in FIGS. 12 and 13 is designed to bend acannula to a desired curvature. It is different from the existing tubeor cannula benders in that it allows the cannula be bent to variousradii of curvature. The cannula bender 30 can also bend the cannula inmore than one plane.

The cannula bender 30 consists of a base 31 with an approximate diameterof from about 1.25 cm to about 8 cm, with a preferred diameter of about3.8 cm. The base which is preferably curved, circular, or oval in shape,serves as a handle by which the cannula bender is grasped. The base 31may be knurled or striated to provide for a better grip.

There are symmetrical curved bolsters having steps 33, 34, 35, and 36 ontop of the base. The stepped configuration provides the higher steps 34,35 with a smaller radius of curvature. The steps range from about 0.6 cmto about 4 cm in height, with a preferred height of about 1 cm. (Twosteps are illustrated but more can be provided).

The cannula 2 is bent against the bolsters 33 or 36 to create thedesired curvature. If a greater degree of curvature is required thecannula may be bent against the higher bolsters 34 or 35 that have asmaller radius. The symmetry of the bolsters allows the cannula to bebent to the right or to the left without having to rotate the cannulabender. This allows for a faster, easier use of the cannula bendershould the need arise during surgery.

The cannula can be bent again in a different plane by rotating thecannula while maintaining the cannula bender in the same orientation.The pre-bent cannula can be contoured against the bolster in a secondplane as long as the curvature is less than the height of the step ofthe bolster.

The entire cannula does not have to be bent, if at all. The purpose ofbending the cannula is for the convenience of the surgeon in passing thesuture to and from the needle(s) to the suture passer, and to manipulatethe suture passer, to each an area in the cavity or joint that wouldotherwise be inaccessible by a straight cannula.

In addition to the suture passer device, the surgical repair kit alsocontains at least two and preferably three needles. These needles can beeither epidural needles or spinal needles. It is preferred that theneedles be epidural needles 18, two of which are of the same length,e.g., about 3.5 inches in length, and one of which is longer, e.g. about4.75 inches in length. It is also preferred that the needles be 18 gaugeneedles. As seen in FIG. 8A, a spinal needle 17 has a bevelled tipwhich, during repair of the meniscus, may accidentally lacerate thearticular cartilage. In contrast, as seen in FIG. 8B, the epiduralneedle 18 has a Huber tip. With the epidural needle it is easier toadvance the needle through tough tissue by using a twisting motion. The"rounded" tip of the epidural needle is less likely to lacerate thearticular surface.

The surgical repair kit preferably comes with at least two needles ofthe same length because the needle which is inserted first becomes bluntafter several insertions. The insertion of the second, generally longer,epidural needle is easier with the use of the parallel needle guide 19as shown in FIGS. 9 and 10. (Longer and shorter needles are utilized toprevent the hubs 29A of adjacent needles from interfering with oneanother by staggering the hub distance from the patient's body). Theparallel needle guide allows for the proper alignment of the needlesthrough which the suture will pass. The parallel needle guide is aseries of at least three, and preferably four to five hollow tube shapedunits 20 longitudinally adhered to each other one on top of the other ina parallel formation. The opening or diameter of each tube shaped unitshould be large enough to allow for the passage of an 18 or 21 gaugeneedle to pass through. The parallel needle guide may be made out ofplastic, paper or metal. The parallel needle guide may be from a mold,or the individual tubes may be individually formed and bonded to eachother. Any method of forming the structure is acceptable.

Additionally, there is at least one stylet typified by stylet 29 shownin FIG. 11 in the surgical repair kit for each needle included in therepair kit. The stylet is kept on the needle until the needle is passedthrough the meniscus. This prevents the needle(s) from being cloggedwith tissue and cartilage as it is pushed through the cartilage. Aneedle clogged with tissue will, of course, not allow the suture to bepassed through the needle to the suture passer.

A template (not shown) is preferably included in the surgical repairkit. This template, which may be printed on the back of the surgicalrepair kit container, may be printed on a paper guide inside themeniscal repair kit, or may be provided on, or as, a plastic guide. Thetemplate is used as a guide for the bending of the cannula.

Each of the items included in the surgical repair kit is sterile.Additionally, each item in the surgical repair kit is preferablyindividually packaged in sterile plastic, paper, metal foil, orcombinations there.of The packaging should be easy to open, so that thecontents thereof are not damaged or do not fall on the operating floorwhile opening. The content of the package and the packaging may besterilized with ethylene oxide or by radiation, or any otherconventional method for the sterilization of packaged elements.

The surgical repair kit which includes the suture passer, at least twosurgical needles of predetermined length, and at least one stylet foreach needle, may also contain an optional third needle of greater lengththan the other two needles, the parallel needle guide, and a template.If the cannula is made of metal, a cannula bender may be included in therepair kit. While the repair kit may be used for any surgery, the repairkit is extremely useful in meniscal repair.

In repairing the middle third of the meniscus, an arthroscope 37 shouldenter through the ipsilateral portal 38 as shown in FIG. 14. The suturepasser 1 should enter through the contralateral portal 39. The epiduralneedle is loaded through the hole on one end of the needle guide using aone handed technique to avoid accidental puncture of the surgeon'sopposite hand.

There are three methods of identifying the insertion points for theneedles.

The first method is to view the meniscal tear with the arthroscope, withthe synovial meniscal junction in view, and then advance the arthroscopeto the synovial meniscal junction. The light from the arthroscope willtransilluminate the skin. The point of insertion of the epidural needleshould be slightly distal to this light.

The second method of determining where to insert the needles is to viewthe meniscal tear and to keep the synovial meniscal junction in view.While palpating along the joint line with a tip of a finger or ameniscal probe. The area of maximal wall motion at the synovial meniscaljunction indicates the point at which the epidural needle should beinserted.

The third method is the easiest method in determining the needleinsertion point, if the synovial meniscal junction is accessible to thesuture passer. The tip of the suture passer is pushed against thesynovial meniscal junction and the skin is palpated, with the finger.The area of the tip will indicate the approximate location where theneedle should be inserted.

The needles may be advanced with a twisting motion if difficulty isencountered in penetrating the tough meniscal tissue. As shown in FIG.15, an inner rim 40 of a meniscal tear 41 may be buttressed with the tipof the cannula 2 of the suture passer to stabilize it against theadvancing needle 18.

Using the parallel needle guide, two epidural needles are insertedthrough the guide and across the meniscal tear with a long epiduralneedle 42 being inserted through the needle guide at a desiredseparation distance from the shorter needle (as shown in FIG. 16). Thislonger needle is inserted through the meniscal tissue, preferably behindthe shorter needle. The stylets are removed from the needles. A sutureis passed through the "first" needle. The tip of the cannula of thesuture passer is introduced into the joint cavity through a smallincision. The distal opening of the cannula is placed at or near theopening of the needle through which the suture has been passed. Thereare areas in the joint cavity, although visible through the arthroscopewhich are not accessible with a straight cannula. Consequently, prior tothe introduction of the suture passer, the cannula of the suture passermay be bent on the cannula bender. The curved cannula allows the surgeonto reach remote areas where the meniscus is being repaired.

In a preferred method for passing the suture from the cannula to theneedle, the needle, preferably an epidural needle with a Huber tip,engages the opening of the cannula (FIG. 17). The more posterior needleis advanced into the joint and the surgeon captures the tip of theneedle with the tip of the cannula. For ease of passage, it ispreferable that the cannula and needle meet at about a 15°-20° angle.The opening of the needle should be facing away from the apex ofengagement between the cannula and the needle. The suture is passeddirectly from the cannula into the tip of the needle or vice versa.

By careful manipulation, a suture 43 is fed through the needle and intothe cannula. With the tip of the cannula and the needle securelyengaged, the suture is fed (FIG. 18) into the hub of the needle until itexits the proximal end of the cannula at the handle of the suturepasser. It is advisable to pull the suture three quarters of the waythrough. The suture is then looped onto the distal guide and is threadedback into the cannula. The suture is then engaged onto the proximalguide (FIG. 19).

The first needle is removed, and with the two limbs of the suture heldseparately by the proximal and distal loops, one limb of the suture isadvanced by sliding the suture with the index finger over the topsurface of the handle so that the suture emerges from the tip of thecannula (FIG. 20). The suture, via the suture passer, is now fullycontrollable with one hand. The tip of the second needle and the tip ofthe cannula are brought into close proximity and the suture is passedfrom the loaded suture passer into the opening of the second needle andthrough the second needle. The suture is advanced until it exits fromthe hub of the second needle (FIG. 21). The second needle is partiallyremoved so that the tip of the second needle is buried within the softtissue 44 (FIG. 22). The suture is disengaged from the guides on thehandle of the suture passer.

While grabbing both ends of the suture, the suture is pulled through thecannula into a joint 45 (Figure 23). With the second needle still inplace, a stab incision is made along the shaft of the second needle downto the level of a joint capsule 47 but not beyond (FIG. 24). The secondneedle is removed and the soft tissue is dissected all the way down tothe joint capsule by spreading the soft tissue with a pair of smallforceps 48 (FIG. 25). The other limb of the suture is then retrievedthrough this "stab incision" with a meniscal probe 49 (FIG. 26) and thesutures are tied after all of the sutures have been put into place.

For a meniscal tear in the more posterior position, the straight cannulacan enter through the ipsilateral portal to reach the posterior horn ofthe meniscus (FIG. 27a). The cannula can also be contoured to reach aspecific zone of the meniscus with the use of the cannula bender and thetemplate for the various zones (FIG. 27b).

During repair of the meniscus, if the tip of the cannula cannot engagethe tip of the needle during initial passage of the suture, the suturemay be fed through the posterior needle into the joint. The suture maythen be retrieved with a snap or a suture retriever 50 (FIG. 28). Thefirst needle is removed and the suture is fed into the cannula in aretrograde direction (FIG. 29). The cannula is advanced into the jointalong the suture. The suture is then looped onto the distal guide andthreaded back into the cannula until it reaches the tip of the cannula.The suture is then engaged onto the proximal guide (FIG. 30).

The suture is then advanced into the tip of the second needle underarthroscopic visualization (FIG. 31). The suture is advanced until itexits from the hub of the second needle. The second needle is slightlypulled back so that the tip of the needle is buried within the softtissue. The suture is disengaged from the guides on the handle of thesuture passer and the suture is pulled through the cannula into thejoint.

The suture passer can also be used to pass the suture from the suturepasser to the hollow needles, instead of vice versa. The suture passeris loaded with a suture so that the suture engages the first and secondguide means with the "beginning" and "terminal" ends of the sutureprotruding from the distal opening of the hollow cannula. The beginningend of the suture is fed from the distal opening of the hollow cannulathrough the opening of the first hollow needle until it exits the firsthollow needle. The terminal end of the suture is passed from the distalopening of the hollow cannula through the opening of the second hollowneedle until it exits the second hollow needle. The suture is thencompletely disengaged from the suture passer, the suture passer isremoved, both hollow needles removed and the suture is tightened andtied.

By maneuvering the tip of the needle with one hand and the cannula inthe other when both tips are in close proximity, the suture may beadvanced.

In another method, the suture protrudes from the cannula by about 1/2 to1 centimeter. By manipulating the tip of the cannula with the tip of theneedle, one can engage the suture into the tip of the needle and advancethe suture.

An arthroscopic video camera may be used to visualize the suturing. Thesurgeon manipulates the suture preferably while viewing a video monitorconnected to the camera.

A recommended suture for use is the Ethicon "0" PDS suture. The lengthof the suture should be at least 27 inches and preferably 36 inches inlength. With other types of monofilament suture, the strand tends to becurled when removed from the packaging. It is necessary to straightenout the suture prior to use, as the ends of the suture must be straightfor ease of passage of the suture between the cannula and the needle.

It is preferable that the suture being used have distinct markings togive an enhanced visual indication of the movement of the suture.Different types and colors or markings along the length of the suturewill indicate how much suture has been advanced. It is preferred thatthe suture have distinct markings at the beginning and terminal ends ofthe suture, which could indicate the length of the suture which has beenadvanced.

If the meniscal tear is large, the repair operation should begin at theanterior portion of the tear. After the placement of the anteriorsuture, it will be easier to work along the anterior joint line to theposterior part of the tear. The medial meniscus is repaired with theknee in near extension or slight flexion. The lateral meniscus isrepaired with the knee in 45° to 90° flexion.

In a further modification of the invention, the suture passer may beformed in a modular fashion so that a variety of different cannulas canbe attached to its handle. These cannulas may be blunt (in the mannershown in FIGS. 1-3, 6, 7A, 7B, 14-23, 27A, 27B and 29-31) or sharplypointed, and they may be pre-formed straight (in the manner shown inFIGS. 1-3, 6, 7A, 7B, 14-23, 27A and 29-31) or already curved.

More particularly, and looking now at FIGS. 32-43, a modular suturepasser 100 is shown. Suture passer 100 generally comprises a cannula 200and a handle 300. Cannula 200 and handle 300 are configured forreleasable locked engagement with one another.

More particularly, and still looking now at FIGS. 32-43, cannula 200comprises an elongate tubular member 202 and a thin, outwardly extendingradial fin 204. Fin 204 is attached to tubular member 202 adjacent tothe tubular member's proximal end 206 (see FIGS. 36, 38 and 40).

Tubular member 202 may be formed out of a single piece of tubing ifdesired. Alternatively, it may be formed out of a plurality ofconcentric tubes so as to increase the rigidity of tubular member 202,e.g. to assist in penetrating tough tissue. In the specific embodimentshown in FIGS. 32-43, tubular member 202 is shown formed out of threeconcentric tubes 202A, 202B and 202C (see FIGS. 40 and 42). The innerdiameter of tube 202C is selected so as to engage the outer diameter oftube 202B, and the inner diameter of tube 202B is selected so as toengage the outer diameter of tube 202A. In addition, tube 202A is sizedso as to have the longest length, tube 202C is sized so as to have theshortest length, and tube 202B is sized so as to have an intermediatelength. The proximal ends of tubes 202A, 202B and 202C are aligned withone another so that tube 202B projects out of tube 202C and tube 202Aprojects out of tube 202B, and then the resulting structure is securedin place by welding or some other suitable process. It will beappreciated that a cannula 200 comprising the foregoing structure willbe quite strong.

The cannula's fin 204 comprises a main portion 208 and a tab portion 210(see FIGS. 36, 38, 40 and 41).

Main portion 208 has a proximal edge 212 (see FIG. 40) which issubstantially aligned with the proximal end 206 of the cannula's tubularmember 202. Main portion 208 also has a bottom edge 214 which is spacedfrom the outer surface of tubular member 202 by a distance which isslightly less than the height of handle 300 (see FIG. 36). Main portion208 also has a distal edge 216 (see FIG. 40) which extends between themain portion's bottom edge 214 and the outer surface of tubular member202.

Tab portion 210 extends centrally and proximally from proximal edge 212of the fin's main portion 208 (see FIG. 40). Tab portion 210 is locatedin the same plane as main portion 208 (see FIG. 41) and is preferablygenerally rectangular in shape, although other tab shapes may also beused without departure from the present invention. Tab portion 210includes an upper tab projection 218 (see FIG. 40) which projectsupwardly out of the tab portion's upper edge 220, and a lower tabprojection 222 which projects downwardly out of the tab portion's loweredge 224. Upper tab projection 218 defines an upper, distally facing tabshoulder 226, and lower tab projection 222 defines a lower, distallyfacing tab shoulder 230. Tab projections 218 and 222 are located betweenthe proximal edge 212 of the fin's main portion 208 and the proximaledge 232 of tab portion 210 (see FIG. 40). Tab shoulders 226 and 230 arealigned with one another.

Looking next at FIGS. 32-39 and 39A, handle 300 comprises a first sutureguide 302 and a second suture guide 304.

First suture guide 302 includes an eyelet 306 (see FIGS. 32 and 33). Apassageway 308 is provided to permit a length of suture (not shown inFIGS. 32-39 and 39A) to be slid transversely into eyelet 306.

Still looking now at FIGS. 32-39 and 39A, second suture guide 304comprises a generally semi-cylindrical member extending upwardly out ofthe handle's top side, between the handle's distal upper surface 310(see FIGS. 32-34) and its proximal upper surface 312. An axial bore 314(see FIGS. 36 and 38) extends longitudinally through second suture guide304. A top slot 316 (see FIGS. 32-34 and 36) extends down into secondsuture guide 304, transverse to the longitudinal axis of the handle. Aright side slot 318 (see FIGS. 33 and 36) extends between the secondsuture guide's distal end 320 and its top slot 316. A left side slot 322(see FIG. 32) extends between the second suture guide's proximal end 324and its top slot 316. Top slot 316, right side slot 318 and left sideslot 322 effectively bifurcate second suture guide 304 into a pair ofclosely spaced, oppositely extending fingers. These fingers can beconsidered to be somewhat analogous to the fingers 14-16 shown in FIGS.7A and 7B and described above. In view of the foregoing construction, alength of suture (not shown in FIGS. 32-39 and 39A) may be alignedparallel to the second suture guide's top slot 316, then dropped intothe top slot, and thereafter rotated 90° into the right side slot 318and 90° into the left side slot 322, so that the suture enters theinterior bore 314 of second suture guide 304.

Still looking now at FIGS. 32-39 and 39A, handle 300 also comprises afirst bore 326 (see FIGS. 36 and 38) which extends proximally andaxially from the distal end of the handle toward the proximal end of thehandle. First bore 326 includes a stop 327 (see FIGS. 36 and 38) at itsproximal end. First bore 326 is sized so as to be able to receive theproximal portion of a cannula's tubular member 202. First bore 326 ispositioned so that when the cannula's tubular member 202 is received inthe handle's first bore 326, the central lumen of the tubular memberwill open onto the handle's distal upper surface 310, between firstsuture guide 302 and second suture guide 304 (see FIG. 36).

A vertical slot 328 (see FIGS. 35-37, 37A, 38, 39 and 39A) extendsdownwardly from first bore 326. Vertical slot 328 opens on the handle'sbottom surface 330 (see FIG. 36), and is sized to receive the mainportion 208 of a fin 204 when a cannula 200 is mounted to handle 300.

Still looking now at FIGS. 32-39 and 39A, a snap lock 332 (see FIGS.35-37, 37A, 38, 39 and 39A) is formed at the proximal end of verticalslot 328. Snap lock 332 comprises a cavity 333 formed in handle 300immediately proximal to slot 328 (see FIGS. 35-37, 37A and 38). Cavity333 is sized to receive the tab portion 210 of a fin 204 when a cannula200 is mounted to handle 300. The right sidewall of cavity 333 comprisesa proximally extending continuation 334 (see FIGS. 37A and 39A) of theright sidewall of vertical slot 328. Continuation 334 has a lengthsubstantially equal to the distance between the proximal edge 212 of thecannula's main fin portion 208 and the distally facing tab shoulders 226and 230 of the cannula's tab portion 210 (see FIG. 40). The leftsidewall of cavity 333 comprises an outward tapering 336 (see FIGS. 37Aand 39A) of the left sidewall of vertical slot 328.

Snap lock 332 also comprises a sloping upper sidewall projection 338(see FIGS. 36 and 38) extending inwardly into cavity 333 from thecontinuation 334 of the right sidewall of vertical slot 328, and asloping lower sidewall projection 340 (see FIGS. 37, 38 and 39A)extending inwardly into cavity 333 from the same continuation 334. Uppersidewall projection 338 defines an upper, proximally facing sidewallshoulder 342 (see FIG. 38) and lower sidewall projection 340 defines alower, proximally facing sidewall shoulder 344 (see FIGS. 37A, 38 and39A). Upper sidewall shoulder 342 is aligned with lower sidewallshoulder 344.

Upper and lower sidewall projections 338 and 340 are located such thatas the tab portion 210 of a given cannula 200 enters the handle's cavity333, the cannula's upper and lower tab projections 218 and 222 will snapover and lockingly engage the handle's upper and lower sidewallprojections 338 and 340 when the cannula is fully inserted into thehandle's first bore 328. In particular, when the assembly is in thislocked condition, the cannula's distally facing upper tab shoulder 226will engage the handle's proximally facing upper sidewall shoulder 342,and the cannula's distally facing lower tab shoulder 230 will engage thehandle's proximally facing lower sidewall shoulder 344 (see FIG. 36).

When a given cannula 200 has been mounted to the handle 300 in theforegoing manner, rotational movement of the cannula relative to thehandle is precluded by the engagement of the cannula's main fin portion208 with the sidewalls of the handle's slot 328. In addition, axialmovement of the cannula relative to the handle is precluded (i) in theproximal direction by the engagement of the proximal end 206 of thecannula 200 with the stop 327 located at the proximal end of thehandle's first bore 326, and (ii) in the distal direction by theengagement of the cannula's two distally facing tab shoulders 226 and230 with the handle's two proximally facing sidewall shoulders 342 and344.

The handle of the modular suture passer 100 also includes means forreleasing a cannula from its locking engagement with the handle. Moreparticulary, and still looking now at FIGS. 32-39 and 39A, a secondlongitudinal bore 348 (see FIGS. 36, 37, 37A, 38, 39 and 39A) extendsbetween the proximal end 350 (see FIG. 36) of cavity 333 to the proximalend 352 (see FIGS. 36 and 38) of handle 300. Second bore 348 includes adistal portion 354 (see FIGS. 36 and 38) communicating with cavity 333,an enlarged intermediate portion 356, and a proximal portion 358 openingon the handle's proximal end 352. A proximally facing annular shoulder360 (see FIGS. 36 and 38) is formed at the intersection of the bore'sdistal portion 354 with its intermediate portion 356, and a distallyfacing annular shoulder 362 is formed at the intersection of the bore'sproximal portion 358 with its intermediate portion 356. The bore'sdistal portion 354 is sized so that the proximalmost portion of cannulatab 210 may be contained therein (see FIG. 36).

A release rod 364 (see FIGS. 36, 37, 37A, 38, 39 and 39A) is slidablydisposed in second bore 348. More particularly, release rod 364comprises a distal portion 366 (see FIGS. 36 and 38), an enlargedintermediate portion 368, and a proximal portion 370. A distally facingannular shoulder 372 (see FIGS. 36 and 38) is formed at the intersectionof the rod's distal portion 366 and its intermediate portion 368, and aproximally facing annular shoulder 374 is formed at the intersection ofthe rod's proximal portion 370 and its intermediate portion 368. Aspring 376 (see FIGS. 36 and 38) is captivated between bore shoulder 360and rod shoulder 372 so as to bias release rod 364 proximally (see FIGS.36 and 37). The engagement of rod shoulder 374 with bore shoulder 362limits proximal movement of release rod 364. Release rod 364 can beurged distally against the power of spring 376 by pressing on the rod'sproximal end 378 (see FIGS. 38 and 39). The distal end of release rod364 is bevelled so as to form an end surface 380, a deflection surface382, and a drive surface 384 (see FIG. 37A).

To release a cannula 200 from handle 300, the proximal end 378 (seeFIGS. 36 and 37) of release rod 364 is forced distally so as to move therelease rod against the biasing force of spring 376. As release rod 364moves distally through handle bore 348, the release rod's deflectionsurface 382 (see FIG. 37A) will engage the proximal edge 232 (see FIG.40) of the cannula's tab portion 210 and deflect the tab portion 210laterally so as to disengage the cannula's distally facing tab shoulders226 and 230 (see FIG. 40) from the housing's proximally facing sidewallshoulders 342 and 344 (see FIGS. 36 and 38). As release rod 364continues to move distally through handle bore 348, the release rod'sdrive surface 384 (see FIG. 37A) will engage the cannula's proximal edge232 (see FIG. 40), whereby the entire cannula will be driven distally sothat the cannula's two tab projections 218 and 222 will clear thehousing's two sidewall projections 338 and 340 (see FIGS. 38, 39 and39A). This will unlock the cannula from the handle. Cannula 200 maythereafter be manually withdrawn from the handle by pulling the cannulain a distal direction.

Thus, it will be seen that a variety of different cannulas 200 can bereleasably attached to the handle 300. These cannulas can be blunt orsharply pointed, and they may be straight or curved, as required for aparticular surgical procedure.

For example, a straight, sharply pointed cannula 200 is shown in FIGS.32-43. Preferably, the pointed distal end of this cannula is formed bycutting the distal end of the cannula at a first, relatively sharp angleso as to form a sharp penetrating edge at 270 (see FIGS. 40, 42 and 43),and then at a second, somewhat less severe angle so as to form ashallower tapering edge at 272. The cannula is preferably blunted orrounded off at 274 (see FIGS. 42 and 43) so as to minimize thepossibility of damaging a suture during a tissue piercing operation, aswill hereinafter be discussed in further detail.

FIGS. 44 to 49 exemplify some of the other cannula configurations whichmay be utilized with handle 300. Specifically, these exemplaryconfigurations include a curved, sharply pointed cannula 200 (FIG. 44);another curved, sharply pointed cannula 200 (FIG. 45); still anothercurved, sharply pointed cannula 200 (FIG. 46); a "cork-screw", sharplypointed cannula 200 (FIG. 47); a straight, blunt cannula 200 (FIG. 48);and a curved, blunt cannula 200 (FIG. 49). If desired, a reinforcingtube 202D (see FIGS. 45, 46, 47 and 49) can be added to the tubularmember 202 so as to further strengthen the tube against undesirablebending during tissue penetration.

Still other possible cannula configurations will be well known to thoseskilled in the art.

It is anticipated that a surgeon will select a particular cannula 200depending on the particular surgical procedure which is to be carriedout. For example, if the surgical procedure of FIGS. 14-26 or thesurgical procedure of FIGS. 27A, 27B and 28-31 is to be carried out, thesurgeon might select the straight, blunt cannula of FIG. 48 or thestraight, sharply pointed cannula of FIGS. 40-43.

It will also be appreciated that modular suture passer 100 can be usedin many different ways to pass a length of suture through tissue. Forexample, FIGS. 50-52 illustrate one possible way in which a straight,sharply pointed cannula 200 might be used to pass suture through a pieceof tissue 500.

More particularly, and looking now at FIG. 50, a length of suture 400may be attached to the suture passer 100 by threading the suture throughthe suture passer's proximal guide member 304, through its cannula 200and then back around its distal suture guide 302. This will allow thesurgeon to adequately control the two ends of the suture during thetissue penetration operation.

The pointed distal end of the suture passer's cannula 200 is then driveninto and through the piece of tissue 500 (see FIG. 51). As this occurs,the suture extending out of the cannula's sharp distal tip will beforced against the blunt heel 274 (see FIG. 43) of the cannula. Thecannula's blunt heel 274 will support the suture during tissuepenetration and prevent the cannula from cutting or otherwise damagingthe suture as the suture is carried through the tissue. Then the loop ofsuture residing at the far side of tissue 500 may be grasped by anothertool (not shown), one or both of the suture ends freed from the suturepasser 100, and suture passer 100 withdrawn from tissue 500 (see FIG.52). At this point the suture will have been passed through tissue 500,with a loop of suture positioned on one side of the tissue and the twofree suture ends positioned on the other side of the tissue.

FIGS. 53-55 illustrate how a simple stitch can be established across twopieces of tissue using the present invention. More particularly, alength of suture 400 is first loaded onto suture passer 100 by feedingone end 400A of the suture into the suture passer's cannula 200. Sutureend 400A is left sitting within the length of cannula 200. Suture length400B is loaded onto the suture passer's proximal suture guide 304. Theintermediate portion of suture 400 will extend along the handle's distalupper surface 310. Then the distal end of the suture passer's cannula200 is forced through two pieces of tissue 500A and 500B until thedistal end of the cannula exits the tissue. Next, the surgeon urgessuture 400 distally through the cannula until suture end 400A exits thetip of the cannula (see FIG. 53). Then the suture passer is withdrawnfrom tissue 500A and 500B, paying out the suture as it goes, so thatsuture 400 extends through both pieces of tissue (see FIG. 54). Next,suture 400 is withdrawn from the suture passer and suture ends 400A and400B are tied off into a knot (see FIG. 55).

FIGS. 56-58 illustrate how a suture loop can be passed across two piecesof tissue using the present invention. More particularly, a length ofsuture 400 is first loaded onto suture passer 100 by feeding one end400A of the suture into the suture passer's cannula 200. Suture end 400Aextended all the way out the distal end of the cannula (see FIG. 56).Suture end 400A is then brought back to the suture passer's handle, sothat the length of the suture will engage the blunted needle heel 274 asit exits from the cannula (see FIG. 57). Alternatively, suture end 400Acould be left dangling until the force of tissue penetration bringssuture end 400A back against the blunted needle heel 274. Suture length400B is loaded onto the suture passer's proximal suture guide 304. Theintermediate portion of suture 400 will extend along the handle's distalupper surface 310. Then the distal end of the suture passer's cannula200 is forced through two pieces of tissue 500A and 500B until thedistal end of the cannula exits the tissue. As this occurs, the suturewill be carried through the tissue so that a loop of suture will resideon the far side of the tissue (see FIG. 58). Then the suture passer iswithdrawn from tissue 500A and 500B, paying out the suture as it goes,so that both suture ends 400A and 400B will reside on the near side ofthe tissue, with a loop of suture remaining on the far side of thetissue.

FIGS. 59-61 illustrate two different ways a folded suture loop can bepassed across two pieces of tissue using the present invention. Moreparticularly, a portion of suture (i.e., either the two suture ends 400Aand 400B, or the intermediate portion of suture extending between thetwo suture ends 400A and 400B) is placed inside the cannula 200 (seeFIG. 59). Then the cannula is inserted through tissue 500A and 500B sothat the distal end of the cannula emerges on the far side of thetissue. Next, the portion of suture previously held in the cannula(i.e., either the two suture ends 400A and 400B, or the intermediateportion of suture extending between the two suture ends 400A and 400B)is pushed outside the distal end of the cannula (see FIG. 60). Finally,the cannula is withdrawn from the tissue, leaving a loop of tissueresiding on one side of the tissue and the two suture ends residing onthe other side of the tissue (see FIG. 61).

FIGS. 62-64 illustrate how a simple stitch can be converted to amattress stitch with a suture loop using the present invention. Moreparticularly, a loop of suture 402 is first positioned on the far sideof the tissue using the technique of FIGS. 56-58, and a single strand ofsuture 404 is passed through the tissue using the technique of FIGS. 53and 54 (see FIG. 62). Then the end of suture 404 is drawn through theloop of suture 402 (see FIG. 63). Finally, the loop of suture 402 iswithdrawn back through tissue 500A, 500B, carrying the strand of suture404 with it (see FIG. 64).

The foregoing description of the preferred embodiments of the inventionhas been presented for the purposes of illustration and description. Itis not intended to be exhaustive or to limit the invention to theprecise forms disclosed. Many modifications and variations are possiblein light of the above teachings. It is intended that the scope of theinvention not be limited by this detailed description.

What is claimed is:
 1. A suture passer comprising:a longitudinallyextending hollow cannula having a central passage slidingly receivableof a surgical suture; a manually graspable handle for engaging saidhollow cannula for manipulation thereof, said handle having a distalend, a proximal end, and an upper surface; first suture guide meansconnected to said upper surface of said handle proximate to said distalend of said handle for releasably, guidingly holding said surgicalsuture; second suture guide means connected to said upper surface ofsaid handle proximal to said first suture guide means for releasably,guidingly holding said surgical suture; and locking means forreleasably, lockingly maintaining said cannula in a substantially fixedposition relative to said handle; wherein said hollow cannula includes aproximal portion, and further wherein said proximal portion of saidcannula is receivable within a first bore formed in said handle, saidbore terminating at a distal opening adjacent to said upper surface ofsaid handle intermediate said first and second suture guide means.
 2. Asuture passer according to claim 1 wherein said means for releasably,lockingly maintaining said cannula in a fixed position relative to saidhandle comprises:a thin radial fin extending outwardly from saidproximal portion of said cannula; a longitudinal slot extending intosaid distal end of said handle and communicating with said first bore,said slot including a pair of side walls separated by a gap slightlylarger than the thickness of said fin; and means for restricting axialmovement of said cannula relative to said handle; whereby said fin mayslide into said slot as said proximal portion of said cannula is engagedin said first bore.
 3. A suture passer according to claim 2 wherein saidmeans for restricting axial movement of said cannula relative to saidhandle comprises:a tab extending proximally from said fin, said tabincluding at least one tab projection defining a distally facing tabshoulder; a proximal end of said slot; a cavity in said handle locatedimmediately proximally of said slot, said cavity having sidewallsdefining at least one sloping, inwardly extending sidewall projectiondefining a proximally facing sidewall shoulder; and said tab beingconfigured to enter said cavity as said cannula is inserted into saidfirst bore and said fin slides into said slot, such that said at leastone distally facing tab shoulder will form a snap lock engagementagainst said at least one proximally facing sidewall shoulder.
 4. Asuture passer according to claim 3 wherein a second bore extends axiallyand proximately through said handle from said cavity to said proximalend of said handle and a release rod is slidably mounted in said secondbore for reciprocal movement between a distalmost position and aproximalmost position, said release rod having a proximal portionextending proximally of said proximal end of said handle and a distalend, whereby distal movement of said proximal portion of said releaserod will cause said release rod to move from said proximalmost positiontoward said distalmost position so that said distal end of said releaserod will deflect said tab laterally so as to disengage said at least onedistally facing tab shoulder from said lock engagement with said atleast one proximally facing sidewall shoulder.
 5. A suture passeraccording to claim 4 wherein said release rod comprises a bevelleddistal end.
 6. A suture passer according to claim 5 wherein said releaserod comprises a drive surface proximal to its bevelled surface, andfurther wherein distal movement of said proximal portion of said releaserod from said proximalmost position to said distalmost position willcause said drive surface to engage said tab and move said cannuladistally after said at least one distally facing tab shoulder isdisengaged from said at least one proximally facing sidewall shoulder.7. A suture passer according to claim 4 wherein said release rod isbiased toward its proximalmost position.
 8. A suture passer according toclaim 1 wherein said cannula is sharply pointed at its distal end.
 9. Asuture passer according to claim 8 wherein said cannula is rounded offat the heel of its tip so as to minimize the possibility of damagingsuture during a tissue piercing operation.
 10. A suture passercomprising:a longitudinally extending hollow cannula having a centralpassage slidingly receivable of a surgical suture; a manually graspablehandle for engaging said hollow cannula for manipulation thereof, saidhandle having a distal end, a proximal end, and an upper surface; firstsuture guide means connected to said upper surface of said handleproximate to said distal end of said handle for releasably, guidinglyholding said surgical suture; second suture guide means connected tosaid upper surface of said handle proximal to said first suture guidemeans for releasably, guidingly holding said surgical suture; andlocking means for releasably, lockingly maintaining said cannula in asubstantially fixed position relative to said handle; wherein said firstsuture guide means comprises a vertically upstanding eyelet, said eyeletdefining an opening oriented transversely to said handle, and apassageway into said eyelet adjacent to the distalmost point ofattachment of said eyelet to said handle, said passageway being sized toreceive a transverse cross-section of said surgical suture therethrough.11. A suture passer comprising:a longitudinally extending hollow cannulahaving a central passage slidingly receivable of a surgical suture; amanually graspable handle for engaging said hollow cannula formanipulation thereof, said handle having a distal end, a proximal end,and an upper surface; first suture guide means connected to said uppersurface of said handle proximate to said distal end of said handle forreleasably, guidingly holding said surgical suture; second suture guidemeans connected to said upper surface of said handle proximal to saidfirst suture guide means for releasably, guidingly holding said surgicalsuture; and locking means for releaseably, lockingly maintaining saidcannula in a substantially fixed position relative to said handle;wherein said second suture guide means comprises a semi-cylindricalmember connected to said upper surface of said handle, wherein an axialbore extends longitudinally through said semi-cylindrical member, a topslot extends down into said member transverse to the longitudinal axisof the handle, a right side slot extends between the member's distal endand said top slot, and a left side slot extends between the member'sproximal end and said top slot.
 12. A method for passing suture throughtissue comprising the steps of:(a) providing a length of suture; (b)providing a suture passer comprising:a longitudinally extending hollowcannula having a central passage slidingly receivable of a surgicalsuture; a manually graspable handle for engaging said hollow cannula formanipulation thereof, said handle having a distal end, a proximal end,and an upper surface; first suture guide means upstanding from saidupper surface of said handle proximate to said distal end of said handleand having therethrough a first passage for releasably, guidinglyholding said surgical suture; second suture guide means upstanding fromsaid upper surface of said handle proximal to said first suture guidemeans and having therethrough a second passage for releasably,guidingly, holding said surgical suture; and locking means forreleasably, lockingly maintaining said cannula in a substantially fixedposition relative to said handle; (c) threading said length of suturethrough said cannula from its proximal end to its distal end; (d)inserting said distal end of said cannula through the tissue; (e)withdrawing said cannula from the tissue, leaving said suture extendingthrough the tissue; and (f) disengaging said suture from said first andsecond guide means; wherein said distal end of said cannula is sharplypointed, the heel of its tip is rounded off, and one end of said sutureextends out of the distal end of said cannula during insertion of saidcannula through the tissue.
 13. A method for passing suture throughtissue comprising the steps of:(a) providing a length of suture; (b)providing a suture passer comprising:a longitudinally extending hollowcannula having a central passage slidingly receivable of a surgicalsuture; a manually graspable handle for engaging said hollow cannula formanipulation thereof, said handle having a distal end, a proximal end,and an upper surface; first suture guide means connected to said uppersurface of said handle proximate to said distal end of said handle forreleasably, guidingly holding said surgical suture; second suture guidemeans connected to said upper surface of said handle proximal to saidfirst suture guide means for releasably, guidingly holding said surgicalsuture; and locking means for releaseably, lockingly maintaining saidcannula in a substantially fixed position relative to said handle; (c)threading said length of suture through said cannula from its proximalend to its distal end; (d) inserting said pointed distal end of saidcannula through the tissue; (e) withdrawing said cannula from thetissue, leaving said suture extending through the tissue; and (f)disengaging said suture from said first and second guide members;wherein the two free ends of said suture are contained in the body ofsaid cannula during insertion of said cannula through the tissue.
 14. Amethod for passing suture through tissue comprising the steps of:(a)providing a length of suture; (b) providing a suture passer comprising:alongitudinally extending hollow cannula having a central passageslidingly receivable of a surgical suture; a manually graspable handlefor engaging said hollow cannula for manipulation thereof, said handlehaving a distal end, a proximal end, and an upper surface; first sutureguide means connected to said upper surface of said handle proximate tosaid distal end of said handle for releasably, guidingly holding saidsurgical suture; second suture guide means connected to said uppersurface of said handle proximal to said first suture guide means forreleasably, guidingly holding said surgical suture; and locking meansfor releasably, lockingly maintaining said cannula in a substantiallyfixed position relative to said handle; (c) threading said length ofsuture through said cannula from its proximal end to its distal end; (d)inserting said pointed distal end of said cannula through the tissue;(e) withdrawing said cannula from the tissue, leaving said sutureextending through the tissue; and (f) disengaging said suture from saidfirst and second guide members; wherein the intermediate portion of thesuture is contained in the body of said cannula during insertion of saidcannula through the tissue, with the two free ends of the suture exitingthe proximal end of the cannula.
 15. A suture passer comprising:acannula having central passage for receiving and supporting slidingmovement of a surgical suture therethrough; a handle fixed to saidcannula; a first suture guide means extending from said handle andhaving a first passage therethrough, said passage being spaced from saidhandle; and a second suture guide means extending from said handle andspaced from said first guide means axially of said handle, said secondsuture guide means having a second passage therethrough spaced from saidhandle; wherein said cannula at its distal end terminates in a planeoblique to the axis of said cannula so as to provide a point at aportion of said distal end of said cannula most spaced from said handle,and a heel at a portion of said distal end of said cannula least spacedfrom said handle, and said heel is defined by an edge portion of saidcannula which is blunted to prevent cutting of the suture by saidcannula heel.